Reality Check: How the Senate TSCA bill would make it harder for EPA to stop products containing toxic chemicals from entering the United States – including chemicals that are already poisoning our drinking water

As the House and Senate try to reconcile their differing (and flawed) versions of the Toxic Substances Control Act (TSCA), evidence keeps mounting about why one particular Senate provision needs to be dropped. The Safer Chemicals, Healthy Families Coalition, of which NRDC is a part, has made clear (here) what changes it feels are needed in the two bills. But I want to focus today on additional evidence of why it's so dangerous that the Senate bill limits EPA's authority to protect the public from chemicals in imported products. I wrote about this provision previously here, but I think it is timely to revisit, to illustrate more directly what the chemical industry is up to, and what is at stake for the health of the American public.

To briefly recap: Under current law, if EPA is concerned about the safety of a chemical, the agency can require companies to provide notice of potential new uses of that chemical before a company can start to manufacture or import the chemical, either in bulk form or as part of a product (called an "article" in the law).  Such notice requirements are one of the few legal tools EPA has to protect the public from problematic new chemicals uses and products. These notice requirements are called "Significant New Use Rules," or SNURs, and they give EPA an opportunity to learn about a potential new use of a substance before it occurs and consider whether some restriction is warranted to protect the public.

Congress granted EPA broad authority to impose these notice requirements when TSCA was enacted in 1976. Over the past 40 years, EPA has used that authority sparingly. Indeed, at the suggestion of the chemical manufacturers, EPA instituted a policy of generally not requiring notice if a chemical was going to enter the country as part of a product (as opposed to in bulk form for processing in the U.S.). However, EPA has always retained the authority to require notice of new uses of chemicals of concern in products, and, in the last several years, has exercised that authority – or proposed to do so -- on a handful of occasions.  In particular, EPA has sought to require notice of potential new uses of chemicals the Agency has identified as top priorities for potential regulatory action, including:

• Benzidine Dyes – benzidine is a known human carcinogen;
• Hexabromocyclododecane (HBCD) –  a flame retardant ingredient linked to hormone disruption, aquatic toxicity and a possible reproductive toxin (also a PBT);
• Polybrominated Diphenyl Ethers (PBDEs) –  another group of flame retardants that are persistent, bioaccumulative and toxic;
• Toluene Diisocyanate (TDI) and related compounds – dermal and inhalation sensitizers that can cause asthma and lung damage; and
• Mercury – you've probably heard of this one, a potent neurotoxin.

The Senate TSCA bill would weaken EPA's notice authority to make it more to industry's liking. It increases the burden of proof EPA has to meet to issue a notice requirement. Under the bill, EPA would need to demonstrate that use of a chemical of concern in any product would likely lead to exposure that causes concern [be likely to harm the public] -- before EPA has any idea about a particular potential use of a chemical or what product(s) it might be used in. Now, EPA just needs to have reason to be concerned about possible new uses of a chemical to require a notice. Under the Senate bill, EPA would have to be able to show that each specific possible new use could lead to a level of exposure that "warrants notification," and to predict any hypothetical use that might someday occur.  In essence, the industry is converting a straight-forward notice requirement into a mandate that EPA use a "crystal ball," to predict each future uses of toxic chemicals and how each one might harm the public. And of course, industry is likely to challenge EPA's predictions in court.

Arguably, the greatest flaw of the Toxic Substances Control Act to begin with is that for most actions it places the burden on EPA to prove that a chemical poses harm (or will pose harm) rather than placing the burden on the chemical manufacturers to demonstrate that their products are safe – unlike the laws that govern pesticides and pharmaceuticals.  Under the current language of TSCA, EPA's burden before requiring notice of a new use is fairly low; which is why it is one of the few provisions of TSCA that has proven to be somewhat effective. The Senate's new notice provision would make the fundamental problem of TSCA even worse by needlessly raising the burden of proof on EPA.

Now we have a new illustration of how bad this could be. EPA is in the middle of an effort now to ratchet down on a high-priority chemical that is both ubiquitous and unsafe, in part by issuing a Significant New Use Notice requirement for new uses of the chemical in products. And the new Senate provision will likely short-circuit EPA's effort.  In recent weeks there have been several news stories on the poisoning of communities' drinking water with perfluorinated chemicals – commonly known for their "non-stick" properties such as in rainproof outdoor gear and in "Teflon" non-stick pans. Several stories have recounted how an entire community in West Virginia had its drinking water polluted from a DuPont factory producing the chemicals, and the ongoing class action litigation resulting from that toxic legacy. See for example the multi-part coverage of reporter Sharon Lerner at The Intercept website, and a profile of the lawyer who took the case on behalf of citizens by Nathaniel Rich in the New York Times Magazine. Even more recently, pollution of drinking water supplies from perfluorinated chemicals (in this case perfluorooctanoic acid or PFOA) in Hoosick Falls, New York and Bennington, Vermont has led to orders not to drink the water. The problem is not limited to West Virginia, New York, and Vermont. According to a report by the Environmental Working Group, since 2013, EPA has found water contaminated with PFOA in 94 water systems in 27 States, and Lerner and other reporters have identified perfluorinated chemicals in drinking water systems in New Jersey, Pennsylvania, New Hampshire, Colorado and Michigan (including the Flint River). Meanwhile, the Food and Drug Administration (FDA) just recently granted a petition from NRDC and several other groups to withdraw its approval to use perfluorinated chemicals in food packaging – such as sandwich wrappers and pizza boxes -- where it has been found to leach into the food supply.

And EPA itself has been somewhat active in this area (though it has dragged its feet on setting a health-protective drinking water standard under the Safe Drinking Water Act). In January 2015, EPA proposed a Significant New Use Rule for "Long-Chain Perfluorinated Chemicals (PFCs)" which are comprised of two sub-categories, Long-Chain Perfluoroalkyl Sulfonate (PFAS) and Long-Chain Perfluoroalkyl Caboxylate (PFAC). These chemicals – which include PFOA, the substance polluting drinking water across the U.S. -- are persistent in the environment, bioaccumulative (meaning they build up in our bodies and the food chain) and toxic – also known as "PBT."

Some of the PFCs, including PFOA, have been associated with potential harm to fetal development, male reproductive systems, pre- and-post natal brain development and cancer. And, as a result of their widespread use, release into the environment, and persistence and bioaccumulative properties, human exposure is widespread.  As the Environmental Defense Fund noted in its comments supporting EPA's SNUR, "PFCs are also routinely detected in human biomonitoring studies: four selected PFCs analyzed in the NHANES 2003-2004 study were detected in 98% of individuals sampled. Further, PFC chemicals are found in breastmilk and umbilical cord blood, indicating a strong likelihood of early life exposure."

EPA's proposed Significant New Use Rule would require that companies intending to manufacture PFC chemicals in the U.S., or to import them into the U.S. – including in products – give EPA notice of their potential new use(s) so that EPA can evaluate whether they pose a risk to human health or the environment warranting some form of restriction. For the past year, EPA has been reviewing comments on its proposed rule mostly from individual companies, and industries (often represented by trade associations or law firms).  Some industry comments on EPA's proposed Significant New Use Rule for perfluorinated chemicals argue on the one hand that industry carefully checks every component of their products for safety, but on the other, says that industry isn't able to trace new uses of PFCs in their operations.

For example, the Semiconductor Industry Association (SIA) states: "[A]dvanced semiconductor manufacturing depends on the use of chemicals that are selected because of their unique chemical and physical properties and functional attributes….These chemicals are carefully integrated into advanced manufacturing equipment and processes and have significant interdependence with other process steps. The process of manufacturing semiconductors involves hundreds of carefully controlled steps in which tools apply specific chemicals – in exactly the right amount, in exactly the right place, at exactly the right time." But SIA also disclosed that in response to a SIA-conducted survey of semiconductor equipment manufacturers and other suppliers "most responded that they do not know if the LCPFAC chemical substances are present because of the complexity of the supply chain."

The Global Automakers and the Auto Alliance state: "By the time it is incorporated into a finished automobile, [each] part will have undergone intensive efficacy testing and will have been assessed for compliance with state, federal and international safety standards and environmental regulations." But they also state that, because there are so many parts and components in a car, supplied by a global supply chain, the proposed notice requirement for new uses of chemicals in their products is too burdensome and should be dropped by EPA. It is a particular version of "too big to fail": these toxic chemicals could be anywhere (or everywhere) so we can't possibly account for them or be held responsible for doing so.  

That is interesting for a couple of reasons.  First, it suggests that many companies do not have a full grasp of which chemicals are in the products that they are selling in the U.S., including products that we bring into our homes. That lack of knowledge is increasingly alarming as evidence continues to mount that it is exactly such products, frequently imported, that for many people are the major sources of exposure to toxic chemicals of concern – including carpets, furniture, building materials, electronics, cleaning supplies, toys, mattresses, baby products, clothing, and other objects that literally surround us in our daily lives (not just at home, but at work, school, and even in our cars).  

Second, the industry's general failure to know what chemicals are in the supply chain and in their products is under challenge – the ground is shifting at the state level, in Europe (under its "REACH" regulation), and in the marketplace in the U.S. – as customers want to know, and will increasingly demand to know – what chemicals are contained in products.

Third, if the industries themselves are saying that they don't know which chemicals are in their own products, how can EPA be expected to predict future uses in consumer products, and the likelihood of exposure from each use, with even less information than the product-makers themselves?! Yet that's exactly the burden the Senate bill would impose on EPA. It requires EPA to make an "affirmative finding" about the potential for exposure to a chemical on an article-by-article basis – including in articles and for uses that EPA has no reason to anticipate. This will either tie EPA up in knots trying to comply, or, more likely -- and surely industry's preference -- it will scare away EPA from even attempting to apply notice requirements to uses of chemicals in products at all.

Aren't these the kind of constraints EPA faces under every other aspect of TSCA, and wasn't removing such barriers the whole point of "reform" in the first place? And if the EPA doesn't accurately guess all the potential new uses, or is unable to get over the newly erected hurdle that this bill seeks to impose, then more products containing Long-Chain PFCs will continue to flow into the U.S. with no advance notice to EPA, and no opportunity to halt or even limit their uses. The Senate provision will be the opposite of "reform" – it will make it harder for EPA to keep track of and prevent exposures to PFCs – and other dangerous chemicals – that are already causing problems all over the country.  

The truth is that the industry authors (and supporters) of this provision know that it is designed to prevent EPA from successfully requiring the kind of reporting EPA is now seeking for Long-Chain PFCs, and other problematic chemicals that threaten our health. The Senate provision is a direct industry response to EPA's recent efforts to do a better job of informing and protecting the public from a set of the chemicals the Agency has identified as some of its top concerns.

EPA has made clear that it thinks PFCs are dangerous and require regulation. Here is part of what EPA had to say about the health risks posed by long-chain PFCs in its 2009 Action Plan:

Long-chain PFCs are a concern for children's health. Studies in laboratory animals have demonstrated developmental toxicity, including neonatal mortality. Children's exposures are greater than adults due to increased intakes of food, water, and air per pound of body weight, as well as child-specific exposure pathways such as breast milk consumption, mouthing and ingestion of non-food items, and increased contact with the floor. Biomonitoring studies have found PFCs in cord blood and breast milk, and have reported that children have higher levels of some PFCs compared to adults. Thus, given the pervasive exposure to PFCs, the persistence of PFCs in the environment, and studies finding deleterious health effects, EPA will examine potential risks to fetuses and children. [Note that EPA's analysis of the PFCs was based in part on animal studies, not unvalidated models and test methods that have not been proven to be the equivalent to (let alone better than) the animal based studies. The Senate bill also tries to make it harder to conduct animal studies.]

And here is some of what EPA had to say about the exposure to PFCs in its 2009 Action Plan:

Manufacturing releases [of PFOA and PFOS] are known to have contaminated local drinking water supplies in the immediate vicinity of some industrial plants, leading to localized elevated blood levels. [read the Sharon Lerner and NYT Magazine articles linked-to above for an illustration of the monumental human pain and suffering that is hidden in that one sentence of EPA's report] The widespread presence of PFOA and PFOS precursors in human blood samples nationwide suggest other pathways of exposure, possibly including long range air transport, and the release of PFOA and PFOS from treated articles. [emphasis added] ...

Children are particularly susceptible to exposure from inhalation of PFC off-gassing from carpet and carpet protectants during their earliest years when they are lying, crawling, and spending large amounts of time playing on the carpet… Consumers and children may also be exposed to PFCs in apparel, home textiles, thread sealant tape, floor wax, contact paper and paper coatings. Some of these articles such as paper coatings for foods cannot be ruled out for the ingestion exposure pathways for children and adults depending upon how the PFCs in the paper contacts the food and subsequently humans… Rainwater containing PFCs may contribute PFCs to vegetables and fruits in home gardens, crops grown on commercial crop lands, drinking water reservoirs, and surface waters from which drinking water is withdrawn.

Since EPA's Action Plan was released, it has taken some steps to limit use and exposure in the U.S. In 2013, EPA issued a Significant New Use Rule for perfluorinated substances that applied specifically to use in carpets – so that now EPA will get notice of any proposed new uses of PFCs in that particular product. The current proposed Significant New Use Rule, which will impose the same notice requirement to PFCs in any other product, is the next step necessary to ensure the public is protected from exposure to these toxic substances not just from one new product, but from any new product. Meanwhile, eight companies that manufacture PFCs agreed to voluntarily stop manufacturing them in the U.S., -- phasing production out over a ten-year period -- with DuPont having just ended its domestic production of PFOA in December 2015.

The manufacture of perfluorinated chemicals in the U.S. has come to an end, but their ongoing use in products has not.  As comments in response to EPA's proposed Significant New Use Rule make clear, there are hundreds of ongoing uses for these chemicals that will continue to enter the U.S.  The Significant New Use Rule seeks to at least partially stem the flood of perfluorinated chemicals by requiring notice of potential new uses. Importantly, that includes new uses of perfluorinated chemicals that are not even on the TSCA Inventory. EPA's current regulations allow a new chemical that is not on the TSCA Inventory, and has not undergone Pre-Manufacture review as a new chemical, to be imported into the United States in products ("articles"). So the only thing potentially stopping new, untested, and unexamined perfluorinated chemicals (or any other such chemical) from being manufactured and put into common household products in another country and shipped to the United States is the authority of EPA to get notice of the potential use of that chemical via a Significant New Use rule.

The SNUR provision in the Senate bill needs to be removed. There's nothing sacrosanct about the Senate bill and this provision. Indeed, it was added relatively late in the process with little or no discussion.

EPA itself has not always helped. Defenders of the provision sometimes say, "EPA says this provision is fine, it doesn't change their current practice." In the first place, whatever EPA officials might have said behind the scenes over the past year to Members of Congress, EPA has raised concerns about the provision in its official correspondence.  In a recent letter to the House and Senate members most directly involved in the TSCA issue, EPA stated that the Senate provision could "make it harder for EPA to require notification for uses not currently foreseen" and "Even for currently envisioned uses it may generate litigation over an EPA finding that the potential for exposure through an article or category of articles is 'reasonable.'"  Prior to that statement from the EPA, apparently some EPA officials had been saying first, that the provision didn't change their current authority, and when that analysis didn't hold water, shifted to the argument that the provision would not change EPA's "current practice." That is also wrong, but more importantly, even if it were true, it wouldn't be relevant to the discussion because the statutory scope of EPA's authority should not be reduced to whatever EPA is choosing to do at a particular point in time. The point of law is not to codify the weakest EPA interpretations of what needs to be done to protect the public.  

In any event, whatever EPA previously thought about the provision, the chemical industry clearly believes it is imposing new legal limits on the agency – they aren't trying to ratify EPA's current practice on requiring notice of potential use of chemicals in products, they are trying to shut it down. And what matters most is not what current EPA officials think but how future Administrations and courts will interpret the new statutory language. And the words clearly change the policy.

Rumor has it that this provision is something that Senator Inhofe of Oklahoma -- Chair of the Senate Environment Committee – now says he "must have" as part of the negotiations to reconcile the House and Senate bills (apparently it is not the only thing he "must have" he also "must have" the changes that would make it harder for EPA to review new chemicals for safety that I previously wrote about here). Is there any Member of Congress willing to say that we, the public, must NOT have this provision that will make us less safe?  Will a Member of Congress go to the mat to protect the border security of our country from toxic chemicals?